Expectation Setting for your Patient Advocacy Group (PAG)-Industry Partnership Expectation Setting for your Patient Advocacy Group (PAG)-Industry Partnership Are you a Patient Advocacy Group (PAG) forming a new partnership with a pharmaceutical company or biotech? Are you a sponsor initiating a collaboration with a Patient Advocacy Group (PAG) and looking Read more…
A Collaboration Between PAG/Industry On Target Product Profile (TPP) A Collaboration Between PAG/Industry On Target Product Profile (TPP) PALADIN’s Interactive Guide to help the pharmaceutical industry and patient advocacy groups (PAGs) collaborate on the Target Product Profile (TPP), a critical planning tool used by industry to facilitate communication with the Read more…
Principles for Compensating Patients for Patient Engagement Activities Principles for Compensating Patients for Patient Engagement Activities | The National Health Council A set of best practices from the National Health Council on providing compensation to patients. View Here
Principles on Contracting Between Patient Advocates and Pharmaceutical Companies Principles on Contracting Between Patient Advocates and Pharmaceutical Companies | The National Health Council A set of rationale, examples, and guiding principles for legal agreements between pharmaceutical companies and patients from the National Health Council. View Here
Target Product Profile (TPP) Playbook Target Product Profile (TPP) Playbook | Becca Kirby – 1Day Sooner A guide to designing a formal process for developing TPP, aimed towards anyone looking to scale their TPP process. View Here
Patient Engagement Book of Good Practices Patient Engagement Book of Good Practices | PFMD “An outline of patient engagment initiatives that are considered good practices. “”Patient Engagement Book of Good Practices”” by PFMD (https://patientfocusedmedicine.org/) is licensed under CC BY-NC-SA 4.0. (https://creativecommons.org/licenses/by-nc-sa/4.0/)” View Here
Institutional Review Board Written Procedures: Guidance for Institutions and IRBs Institutional Review Board Written Procedures: Guidance for Institutions and IRBs | OHRP A guidance from the Department of Health and Human Services (HHS’s) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) on procedures for IRB Read more…
Clinical Trials Essentials: What You Need to Know to be a Part of the Latest Research Clinical Trials Essentials: What You Need to Know to be a Part of the Latest Research | NBDF This resource aims to provide patients with information and guidance regarding clinical trials and their participation. Read more…
Inclusion by Design: Building Equity in Clinical Trials Through the Lens of Metastatic Breast Cancer Inclusion by design: building equity in clinical trials through the lens of metastatic breast cancer | The Health Policy Partnership Wilcox H, Wheeler E, Wait S. 2023. Inclusion by design: building equity in clinical trials Read more…
FDA Guidance on Engaging Community and Advocates in Diversity Guidance on Engaging Community and Advocates in Diversity | FDA This FDA guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in Read more…
Creating a Best Practice Template for Participant Communication Plans in Global Health Clinical Studies Creating a Best Practice Template for Participant Communication Plans in Global Health Clinical Studies | Trials ” A proposed template for universally applicable best practices in communication for clinical trial findings in low and middle-income countries. Read more…
Talking to Your Patient About a Clinical Trial Talking to Your Patient About a Clinical Trial | NIH Guidance for physicians on effectively communicating clinical trial consent to patients. Dr. Eric Kodish’s NCI-funded research introduced a sequential approach, with steps covering disease understanding, standard treatments, and clinical trial options, all Read more…
Determining Fair Market Value: Demystifying the Methodology Behind Patient Renumeration Determining Fair Market Value: Demystifying the Methodology Behind Patient Renumeration | PFMD Reviews the challenges and opportunities that arise when seeking to co-create a global methodology and framework for patient FMV that is deemed fair, transparent, and ethical. View Here
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use | ICH ICH unites global regulators and the pharmaceutical industry to develop guidelines for safe, effective medicines. Established in 1990, it has grown to include 21 Read more…
Regulations: Good Clinical Practice and Clinical Trials Regulations: Good Clinical Practice and Clinical Trials | FDA Links to current FDA Good Clinical Practice regulations governing human subject protection and the conduct of clinical trials. These materials contributed significantly to the development of the rules governing these crucial aspects of healthcare Read more…
Enhancing Benefit-Risk Assessment in Regulator Decision-Making Enhancing Benefit-Risk Assessment in Regulatory Decision-Making | FDA An FDA guidance intended to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Agency makes about Read more…
Assessment of the Use of Patient Experience Data in Regulatory Decision-Making Assessment of the Use of Patient Experience Data in Regulatory Decision-Making | FDA Report on how to better communicate and expand the use of patient experience data in regulatory decision-making to the FDA. View Here
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry | FDA Guidance for sponsors intended to support a new drug application or a Read more…
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data | FDA An overview of patient experience data draft guidance. View Here
FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making | FDA A four-part series of Read more…